Advance MCM Regulatory Science ProgramsSupport MCM development and evaluation by establishing regulatory science programs for MCM products, based on both intra- and extramural, collaborative research programs.

ON TRACKON TRACK1. Launch MCM regulatory science program by establishing steering committee/governance board1/15/2011Completed12/23/20102. Initiate intramural component of MCM regulatory science program1/31/2011Completed1/31/20113. Co-sponsor with Institute of Medicine (IOM) a public workshop to obtain external stakeholder input on MCM regulatory science needs3/30/2011Completed3/29-30/2011 [1]4. Continue to assess regulatory science needs through formal request for information (RFI)8/15/2011Completed8/19/20115. Initiate extramural component of the regulatory science program8/15/2011Completed8/19/20116. Establish an MOU with the DoD’s Defense Advanced Research Projects Agency (DARPA) to collaborate on regulatory science research in support of innovative regulatory tools, such as biomimetic models, that can be used in development and approval of MCMs12/30/2011Completed2/7/2011[1] "Advancing Regulatory Science for Medical Countermeasure Development - A Workshop" was held March 29 - 30, 2011. For more details, visit <a href=http://www.iom.edu/Activities/Research/DrugForum/2011-MAR-29.aspx target=”_blank”> http://www.iom.edu/Activities/Research/DrugForum/2011-MAR-29.aspx</a>.Additional milestones are currently under development.